Devices for treatment of body lumens

ABSTRACT

A medical device may comprise a handle portion; an insertion portion having a proximal end portion at the handle portion, wherein the insertion portion includes a lumen therein and a distal end having a distal opening in communication with the lumen; and a member disposed within the lumen, the member having a distal end portion with an imaging device. The member may be configured to transition between a first configuration and a second configuration. In the first configuration, the imaging device may face distally, and, in the second configuration, the imaging device may face proximally. Extending the distal end portion of the member distally past the distal opening may cause the member to transition from the first configuration to the second configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority from U.S. ProvisionalApplication No. 62/713,669, filed on Aug. 2, 2018, which is incorporatedby reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to devices and methods fordiagnosing and/or treating tissue using, for example, endoscopes,bronchoscopes, and ureteroscopes. More specifically, aspects of thepresent disclosure pertain to devices and methods for positioning and/orvisualizing medical devices within body lumens of a subject.

BACKGROUND

Endoscopic, bronchoscopic, or ureteroscopic techniques may be used fordiagnosing, treating, and/or monitoring conditions by advancing toolsand other devices through body lumens. However, it may be difficult toperform procedures in certain body lumens due to a narrow diameter ofthe lumen. For example, it may be difficult to obtain a biopsy or totreat a nodule or lesion in the periphery of the lungs, due to aninability to visualize the periphery lumen using traditional endoscopes.Typical therapeutic and diagnostic endoscopes may be limited in how manygenerations of the bronchi they are able to navigate due to theirrelatively large outer diameter of approximately 6 mm or greater. Manycurrent procedures for obtaining a biopsy of a nodule or lesion in thefifth or higher generation of the bronchi tend to be done blind becauseof the lack of an optics system compatible with biopsy devices and smallenough to provide visualization of peripheral airways. A lack ofvisualization may lead to (a) low yields and/or (b) increased proceduretime resulting from a user's needing to spend additional time to ensurethat a tool is positioned in the correct location.

SUMMARY

Examples of the present disclosure relate to, among other things,devices and methods for positioning and/or visualizing medical deviceswithin body lumens of a subject. Each of the examples disclosed hereinmay include one or more of the features described in connection with anyof the other disclosed examples.

A medical device may comprise a handle portion; an insertion portionhaving a proximal end portion at the handle portion, wherein theinsertion portion includes a lumen therein and a distal end having adistal opening in communication with the lumen; and a member disposedwithin the lumen, the member having a distal end portion with an imagingdevice. The member may be configured to transition between a firstconfiguration and a second configuration. In the first configuration,the imaging device may face distally, and, in the second configuration,the imaging device may face proximally. Extending the distal end portionof the member distally past the distal opening may cause the member totransition from the first configuration to the second configuration.

Any medical device described herein may include one or more of thefeatures described below. The member may include a flat shaft having across sectional width greater than a thickness and having at least onesubstantially planar outer surface. The shaft may be ribbon shaped. Theimaging device may be disposed on a side surface of the member. On thefirst configuration, the distal end portion of the member may formapproximately a right angle relative to a more proximal portion of themember. In the second configuration, the distal end portion of themember may form a curl shape. The member may be configured to transitionbetween the first configuration and the second configuration by movingthe member longitudinally relative to the lumen. A proximal portion ofthe member may be coupled to a hub. The hub may be configured to effectlongitudinal movement of the member relative to the lumen as the hubtranslates relative to the handle portion. The lumen may be incommunication with a first proximal opening in the handle portion andwith a second proximal opening in the handle portion. A tool may beinsertable into at least one of the first and second opening. A firstproximal lumen and a second proximal lumen may join to form the lumen.The member may rest against a side surface of the lumen so that a toolmay be disposed in the lumen along with the member. In the firstconfiguration, a side surface of the lumen may engage a surface of themember. The member may transition from the first configuration to thesecond configuration due to a shape memory of the member. The insertionportion may further comprise a second lumen.

A method of treatment may comprise: advancing an insertion portion of amedical device in a body lumen of a subject; visualizing the body lumenusing an imaging device of a member, wherein the member is disposed in alumen of the insertion portion, and wherein the imaging device facesdistally out of a distal opening of the lumen; moving the memberlongitudinally relative to the lumen, causing the imaging device to belocated distally of the distal opening of the lumen and to faceproximally; after moving the member, visualizing the body lumen usingthe imaging device; inserting a tool into the lumen of the insertionportion; and performing a procedure using the tool.

Any method described herein may include one or more of the features orsteps described below. Moving the member may include sliding a hub at aproximal portion of the member, relative to a handle portion of themedical device. The member may include a flat shaft having a crosssectional width greater than a thickness and having at least onesubstantially planar outer surface. The shaft may be ribbon shaped.After moving the member, a distal end portion of the member may form acurl shape. A second tool may be inserted into a second lumen of themember.

A medical device may comprise: a member having a shaft, an imagingdevice, and an anchor member; a tool having a shaft; and a tether,comprising: a first surface, wherein the first surface is configured soas to slidably engage with the shaft of the member; and a secondsurface, wherein the second surface is configured so as to engage withthe shaft of the tool to secure the tether to the tool as the tetherslides relative to the member.

Any medical device described herein may include one or more of thefeatures described below. The member may be configured to transitionbetween a first configuration and a second configuration. In the firstconfiguration, the imaging device may face distally. On the secondconfiguration, the imaging device may face proximally. The first surfacemay define a first lumen for engaging the shaft of the member, and thesecond surface may define a second lumen for engaging the shaft of thetool. A surface of the tether may include an opening in communicationwith at least one of the first and second lumens. The anchor member mayinclude at least one of the following: an inflatable member, a clip, anda coil. A steering mechanism may have a shaft. The second surface may beconfigured so as to engage with the steering mechanism to secure thetether to the steering mechanism as the tether slides relative to themember.

It may be understood that both the foregoing general description and thefollowing detailed description are exemplary and explanatory only andare not restrictive of the invention, as claimed. As used herein, theterms “comprises,” “comprising,” or any other variation thereof, areintended to cover a non-exclusive inclusion, such that a process,method, article, or apparatus that comprises a list of elements does notinclude only those elements, but may include other elements notexpressly listed or inherent to such process, method, article, orapparatus. The term “exemplary” is used in the sense of “example,”rather than “ideal.” The term “endoscope” may be used herein but is notlimiting. References to endoscopes may also include other medicaldevices, including, but not limited to, bronchoscopes and ureteroscopes.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate examples of the presentdisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIG. 1 shows a schematic cross-section of an exemplary device in a firstconfiguration.

FIG. 2 shows a schematic cross-section of an exemplary device in asecond configuration.

FIG. 3 shows a schematic view of a distal portion of an exemplary devicein a first configuration.

FIG. 4 shows a schematic view of a distal portion of an exemplary devicein a second configuration.

FIG. 5 shows a schematic view of a distal portion of an exemplary devicein a body lumen.

FIG. 6 shows a schematic view of a further exemplary device in a bodylumen.

FIGS. 7A-7C show cross-sectional schematic views of exemplary tetheringdevices.

FIGS. 8A-8B show cross-sectional schematic views of a first exemplaryanchoring mechanism.

FIGS. 9A-9B show cross-sectional schematic views of a second exemplaryanchoring mechanism.

FIGS. 10A-10B show cross-sectional schematic views of a third exemplaryanchoring mechanism.

FIGS. 11A-11C show exemplary steering mechanisms.

DETAILED DESCRIPTION

The present disclosure is drawn to devices, systems, and/or methods fordiagnosing and/or treating tissue using, for example, endoscopes,bronchoscopes, and ureteroscopes. More specifically, aspects of thepresent disclosure pertain to devices and methods for positioning and/orvisualizing tools and/or devices within body lumens of a subject. Inparticular, in at least some aspects, the devices and methods disclosedherein may provide for visualization of an area of interest in a narrowpassageway such as a bronchus. The devices and methods disclosed hereinmay facilitate advancement of tools to a visualized area of interest.Although respiratory anatomy may be referenced herein, reference torespiratory anatomy should not be construed as limiting possibleapplications of the disclosed devices and methods. The disclosed devicesand methods may be suitable for use in a variety of portions of asubject's body, including, for example, urological organs or thedigestive system.

FIGS. 1-2 depict a medical device 10, which may have an insertionportion 12 and a handle portion 14. A proximal end portion of insertionportion 12 may be connected to a distal portion of handle portion 14.Insertion portion 12 may be disposed distally of handle portion 14relative to an operator of device 10. Medical device 10 may be a device,such as an endoscope, ureteroscope, bronchoscope, or other type ofscope, catheter, or sheath. Insertion portion 12 may be inserted into asubject. For example, insertion portion 12 may be inserted into a bodylumen of a subject. Insertion portion 12 may be an elongate member suchas a shaft and may have a longitudinal axis. Insertion portion 12 may besteerable by any suitable mechanism.

Insertion portion 12 may have a distal end portion 16, including adistal end face 18. A lumen 20 may be within insertion portion 12. Forexample, lumen 20 may extend from a proximal portion of insertionportion 12 to distal end portion 16 of insertion portion 12. Alongitudinal axis of lumen 20 may be coaxial with or parallel to alongitudinal axis of insertion portion 12. Lumen 20 may lead to adistally-facing opening 22 in distal end face 18. Lumen 20 may alsoinclude a first proximal portion 24, which may extend into handleportion 14. Lumen 20 may also include a second proximal portion 26. Forexample, lumen 20 may diverge into two proximal portions 24 and 26 at ay-shaped or otherwise shaped junction. Proximal portion 24 may lead toan opening 28 in handle portion 14. Proximal portion 26 may lead to anopening 30 in handle portion 14. Thus, lumen 20 may be bifurcated, withtwo separate access points (opening 28 and opening 30) providing accessto lumen 20.

Insertion portion 12 may also optionally include a second lumen 40.Second lumen 40 may lead to a distal opening 42 in distal end face 18.Second lumen 40 may also lead to an opening 44 in handle portion 14. Inaddition or in an alternative, second lumen 40 may lead to openings 28and/or 30.

A member 50 may be inserted in lumen 20. Member 50 may have an elongatedshape. Member 50 may extend from proximal portion 24 of lumen 20 towardopening 22. Member 50 may be flat or ribbon-shaped. In an alternative,member 50 may not be flat but may have a first flat surface and a secondflat surface. Side surfaces connecting the flat surfaces may be short sothat member 50 is substantially flat. In an alternative, member 50 mayhave a circular, polygonal, ovular, or other cross-section. Member 50may be made at least partially from nitinol and may be made from anitinol ribbon. Member 50 may exhibit shape memory.

Member 50 may include a distal portion 52. Distal portion 52 of member52 may include a camera portion 54. Camera portion 54 may be disposed ona surface of distal portion 52 of member 50. Signal cables may beoperative to provide power to camera portion 54, provide control signalsto camera portion 54, and/or retrieve images from camera portion 54.Such signal cables may be adhered or otherwise attached to a surface ofmember 50 or embedded within member 50. For example, signal cables mayextend from a proximal portion of member 50 toward distal portion 52 ofmember 50. Member 50 may also include other electronics, such asillumination components. For example, member 50 may include one or morelight emitting diodes (LEDs) such as surface LEDs, printed LEDs, orother suitable devices.

A proximal portion of member 50 may be coupled to a hub 60. Hub 60 maybe formed of any suitable material, such as the same material comprisingmember 50 or a material comprising handle portion 14. Hub 60 may beslidably disposed in a mating cavity 62 of handle portion 28. Hub 60 mayhave a clearance fit with mating cavity 62. One or more cables 70 mayextend from a proximal portion of hub 60 and may provide power and/orcontrol signals to camera portion 54 and/or transmit image data fromcamera portion 54. Cables 70 may extend through or along hub 60 andalong member 50 from a proximal portion of member 50 toward a distalportion 52 of member 50. In addition or in an alternative, cables 70 maybe electrically coupled to other cables which extend through or alonghub 60 and/or along member 50.

Sliding hub 60 relative to handle portion 14 and insertion portion 12may cause movement of member 50 relative to handle portion 14 and/orinsertion portion 12. For example, sliding movement of hub 60 proximallyor distally may cause member 50, including distal portion 52 of member50, to move longitudinally (proximally or distally, respectively)relative to insertion portion 12. Hub 60 may be connected to an actuatorfor effecting such sliding motion, or a user may effect a sliding motionvia hub 60 alone. Longitudinal movement of member 50 via, e.g., hub 60,may cause member 50 to transition from a first configuration (FIG. 1 )to a second configuration (FIG. 2 ). In a first configuration (FIG. 1 ),a distal portion 52 of member 50, including camera portion 54, may belocated at or near opening 22 of lumen 20. For example, distal portion52 and/or camera portion 54 may be slightly longitudinally proximal toopening 22, aligned with opening 22, or slightly distal to opening 22.In the first configuration, distal portion 54 may curve upward so thatdistal portion 54 forms roughly a right angle with respect to moreproximal portions of member 50, as shown in FIG. 1 . In such aconfiguration, camera portion 54 may face distally away from distal face18, out of opening 22.

In a second configuration (FIG. 2 ), distal portion 52 of member 50,including camera portion 54, may be located distally of opening 22 oflumen 20. In the second configuration, distal portion 52 of member 50may be curved upward and backward (in the proximal direction). In eitherthe first or the second configuration, member 50 may curve smoothly, sothat no sharp angles are formed in member 50. In an alternative, member50 may include angled and/or hinged portions in distal portion 52. Inthe second configuration, camera portion 54 may face proximally, towardhandle 14. A proximal orientation of camera portion 54 may also includeother directional components. For example, in addition to facingproximally, camera portion 54 may also face an upward or downwarddirection (a direction transverse to the longitudinal axis of member50). For example, in FIG. 2 ., proximally-facing camera portion 54 alsofaces upward in a direction transverse to the axis. In the secondconfiguration, member 50 may roll or curl back on itself by at least 180degrees with camera portion 54 mounted on an outward-facing surface ofmember 50 near an end of the formed curl.

Member 50 may be biased to assume the shape of the second configurationor, in other words, member 50 may be biased so that camera portion 54faces proximally. For example, member 50 may have shape memory. Whenmember 50 is in the first configuration, the size and shape of lumen 20may prevent member 50 from facing proximally. For example a portion ofdistal portion 52 may interact with an interior surface of lumen 20and/or opening 22. For example, a distal edge of member 50 may interactwith a top surface, a bottom surface, and/or a side surface of lumen 20and/or opening 20. Movement of hub 60, which may be connected to aproximal portion of member 50, may cause member 50 to transition fromthe first configuration to the second configuration, and from the secondconfiguration to the first configuration. When hub 60 is moved distally,member 50 may transition to the second configuration. For example,member 50 may transition due to removal of engagement of distal endportion 52 with one or more inner surfaces of lumen 20 and/or opening22. Member 50 may transition due to shape memory or other biasing ofmember 50. When hub 60 is moved proximally, member 50 may transition tothe first configuration. For example, proximal movement of member 50 maycause member 50 to partially unwind due to, for example, engagement ofdistal end portion 52 with one or more surfaces of lumen 20 and/oropening 22. Hub 60 may be omitted, and another actuation mechanism maybe used to transition member 50 from the first configuration to thesecond configuration and from the second configuration to the firstconfiguration.

FIG. 3 shows a close-up of distal end portion 16 with member 50 in thefirst configuration. Distal end portion 52 of member 50 may be orientedso that camera portion 54 faces distally out of opening 22. Distal endportion 52 may lie in a plane that is transverse to the longitudinalaxis of insertion portion 12 and to the longitudinal axis of a proximalportion of member 50. Distal end portion 52 may lie in a plane that isparallel or substantially parallel to a plane of opening 22. As shown inFIG. 3 , opening 42 of lumen 40 may be transverse to distal end face 18.For example, opening 42 may be an elongate opening which is disposedboth on a side surface of insertion portion 12 and on a distal end face18. For example, opening 42 may open to the side and distally.

FIG. 4 shows a close-up of distal end portion 16 in the secondconfiguration. Distal end portion 52 of member 50 may be oriented sothat camera portion 54 faces proximally and is extended distally ofopening 22. Proximally-facing camera portion 54 may also face to theside, in this case upwardly. As shown in FIGS. 2 and 4 , when member 50is in the second configuration, member 50 may occupy only a smallportion of lumen 20 and opening 22 so that a tool 102 may be inserted inlumen 20 along with member 50. For example, member 50 may lie along oneside of lumen 20 such as a bottom side of lumen 20. Tool 102 may be anyof a variety of tools for use in a body lumen of a patient. For example,tool 102 may be a probe such as an ultrasound probe, radio frequencyprobe, and/or cryogenic probe. Tool 102 may also be a forceps, a snare,a basket, a tome, a suction device, or any other type of diagnostic ortherapeutic tool. The examples above are not exclusive; any type of toolor accessory may be used. The fact that tool 102 may be inserted intolumen 20 along with member 50 may mean that a diameter of insertionportion 12 may be smaller than conventional scopes because one lumen canbe used for both a member 50 including camera portion 54 and a tool 102.A smaller diameter of insertion portion 12 may allow use of insertionportion 12 in narrower body lumens. For example, insertion portion 12may be inserted into a subject's lungs, whereas other types of medicaldevices may be limited as to how far they can extend into a body lumensuch as bronchial passages. In addition, because tool 102 and member 50are narrower than insertion portion 12, they may reach further into bodypassages than insertion portion 12 may reach.

As also shown in FIG. 4 , another tool 104 may be inserted into lumen 40and may extend out of opening 44. Tool 104 may include any of the toolsdescribed in connection with tool 102. Tool 104 may exit opening 40 atan angle transverse to a longitudinal axis of insertion portion 12.Alternatively, tool 104 may exit opening 40 parallel to a longitudinalaxis of insertion portion 12.

FIG. 5 depicts medical device 10 in a body lumen. The body lumen shownin FIG. 5 is a bronchial lumen; however, device 10 may be used in anybody lumen. Device 10 may optionally be used in conjunction with anintroduction device 150. Introduction device 150 may be a scope, such asan endoscope, ureteroscope, bronchoscope, duodenoscope, or any othertype of scope, catheter, or sheath. Introduction device 150 may have alarger diameter than device 10. Introduction device 150 may include alumen 152. Lumen 152 may be sized so as to allow passage of medicaldevice 10 through lumen 152. Introduction device 150 may also includeother lumens 154, 156 through which other devices may be passed.Introduction device 150 may be advanced to a certain portion of a bodylumen. Introduction device 150 may reach a point in a body lumen wheredevice 150 is too large in diameter to pass further into the body lumen.Insertion portion 12 may be further advanced into the lumen. The smalldiameter of insertion portion 12 may facilitate advancing insertionportion 12 into a further and/or narrower portion of a body lumen thanother scopes could reach. For example, as described above with regard toFIG. 4 , because tool 102 and member 50 may occupy the same lumen 20, anouter diameter of insertion portion 12 may be smaller than if twoseparate lumens were required for tool 102 and member 50.

When a distal end portion 16 of device 10 is proximal of an area ofinterest, member 50 may be advanced into the second configuration, asshown in FIG. 5 . In the second configuration, camera portion 54 may bedirected toward an area of interest in a body lumen. For example, asshown in FIG. 5 , an area of interest may be located between a distalface 18 of insertion portion 12 and distal portion 52 of member 50.Camera portion 54 may, for example, capture images of a side surface ofa body lumen and/or of a central portion of a body lumen, proximal to alocation of camera portion 54. Tool 102 may be deployed toward the areaof interest. Tool 104 (FIG. 4 ) may also be deployed toward the area ofinterest. Tools 102 and/or 104 may be used to perform therapeutic and/ordiagnostic procedures on an area of interest in a body lumen.

FIG. 6 shows another embodiment according to the present disclosure,which may be used in conjunction with or in an alternative to theaspects described above with regard to FIGS. 1-5 . As shown in FIG. 6 ,a distal portion of a medical device 200 may include an insertionportion 210. Insertion portion 210 may have any of the qualities ofinsertion portion 12 or introduction device 150, described above.Insertion portion 210 may include a camera 212 to provide imaging of abody lumen of a subject. Insertion portion 210 may also include otherfeatures, such as illumination features (not shown). Insertion portion212 may include a lumen 214. Lumen 214 may have any of the qualities of,for example, lumen 152.

A member 220 may be inserted through lumen 214 and may extend out of anopening at a distal end of lumen 214 and on a distal face of insertionportion 212. Member 220 may have any of the qualities of member 50,described above. In an alternative, member 220 may have differingqualities from member 50. For example, member 220 may have a roundcross-section. Member 220 may include a shaft 222, which may extend froma proximal end (not shown) of insertion portion 210, through insertionportion 210, and out an end of insertion portion 210. Member 220 may besteerable (see, e.g., FIGS. 11A-11C, discussed in further detail below).For example, one or more steering mechanisms may be disposed within aninside lumen of member 220 or on an external surface of member 220.Member 220 may have a distal portion 224. Distal portion 224 may includean atraumatic tip. For example, an atraumatic tip may be formed from asoft durometer material, such as silicone, polyurethane, soft durometerpebax, or any other suitable material.

Distal portion 224 may include a camera portion 226 and/or anillumination portion. Camera portion 226 may be disposed in a lumen ofdistal portion 224 or on an exterior surface of distal portion 224.Distal portion 224 may be formed at least partially of transparentmaterial. Camera portion 226 may incorporate an illumination mechanism.Camera portion 226 may include components such as lenses and imagers.Camera portion 226 may be mounted at an angle between 0 degrees and 70degrees relative to a longitudinal axis of member 220. If camera portion226 is mounted at an angle of 0 degrees, an end face of camera portion226 (which, in one example, may include a planar surface of a cover,lens, or the like) may lie flat against the longitudinal axis of member220, or may lie parallel to the longitudinal axis of member 220, suchthat the end face may face a sideways direction. The end face may, forexample, face a direction perpendicular to the longitudinal axis ofmember 220. If camera portion 226 is angled with respect to thelongitudinal axis of member 220, its end face may face either proximally(see, e.g., FIGS. 8A and 8B) or distally (see, e.g., FIGS. 9A, 10A, and10B). The end face may, for example, face a direction transverse to, butnot perpendicular to, the longitudinal axis of member 220. An angle oftilt may be measured between the end face of camera portion 226 and thelongitudinal axis of member 220. Camera portion 226 may be at leastpartially proximally facing so that camera portion 226 may view an areaproximal of camera portion 226. Camera portion 226 may also face in alateral, or side, direction relative to member 220. In an alternative,camera portion 226 may face distally so that camera portion 226 may viewan area distal to camera portion 226. Distal portion 224 may alsoinclude an anchor member 228. Anchor member 228 may be used to securedistal portion 224 in a body lumen of a subject at a location ofinterest. While anchor member 228 is shown being located distally ofcamera portion 226 in FIG. 6 , other configurations are also available.For example, camera portion 226 may be located distally of anchor member228.

A tether 240 may engage with shaft 222 of member 220. FIGS. 7A-7C,discussed in further detail below, show potential configurations oftether 240. Tether 240 may be slidable or otherwise longitudinallymovable with respect to member 220. For example, tether 240 may slidealong shaft 222 of member 220. Tether 240 may have a smallercross-section than a cross-section of lumen 214, so that tether 240 canfit within lumen 214. Tether 240 may be capable of sliding proximally toa proximal portion of insertion member 210 and distally out of anopening of lumen 214. Tether 240 may be prevented from sliding distallypast distal portion 224 of member 220. For example, distal portion 224may be wide enough that tether 240 may not move past distal portion 224.

A tool 250 may also be inserted through lumen 214 and may extend out ofan opening on a distal face of insertion portion 212. Tool 250 mayinclude a shaft 252. Tether 240 may also engage with shaft 252 of tool250. One or more surfaces of tether 240 may have an interference fitwith one or more surfaces of tool 250. Movement of tether 240longitudinally with respect to member 220 therefore may result inlongitudinal movement of tool 250 with respect to member 220. Tool 250may also have an atraumatic tip at a distal portion 254. An atraumatictip of tool 250 may have any of the qualities of an atraumatic tip ofmember 210, discussed above. An atraumatic tip or other feature of tool250 may prevent tether 240 from moving off of a distal end of tool 250,so that tool 250 may be stationary relative to tether 240.

FIGS. 7A-7C depict different exemplary cross-sectional configurations oftethers. As shown in FIG. 7A, an exterior surface 260 of tether 240 mayhave a circular cross-section. Such a circular cross-section is merelyexemplary. Tether 240 may have any suitable cross-sectional shape.Tether 240 may have a lumen 262 formed therein. A shaft 222 of member220 may be slidably disposed within lumen 262. Lumen 262 and shaft 222may be sized and shaped so as to allow for translational sliding oftether 240 along shaft 222 of member 220 while tether 240 is coupled toshaft 252 of tool 250. For example, lumen 262 and shaft 222 may be sizedand shaped so that there is a clearance fit between lumen 262 and shaft222. While lumen 262 and shaft 222 are shown in FIG. 7A as havingcircular cross-sections, lumen 262 and shaft 222 may have any suitableshape and size. For example, shaft 222 may be keyed to lumen 262. Shaft222 and/or lumen 262 may have an ovular, polygonal, or other shape. Forexample, shaft 222 and/or lumen 262 may have a hexagonal or star shape.Alternatively, member 220 may have any of the properties of member 50,described with regard to FIGS. 1-5 above, and tether 240 may beconfigured to work in conjunction with such a member. For example, shaft222 may have a substantially flat shape (width substantially greaterthan thickness), and lumen 262 may have a corresponding substantiallyflat rectangular shape.

Tether 240 may also have another lumen 264 formed therein. Shaft 252 oftool 250 may be disposed within lumen 264. Shaft 252 and lumen 264 maybe sized and shaped so as to have an interference fit or a slightinterference fit with one another. The interference fit or slightinterference fit may serve as a locking and/or mating mechanism betweenshaft 262 and lumen 264, securing the two together during translationalmovement relative to shaft 222. While lumen 264 and shaft 252 are shownin FIG. 7A as having a circular cross-section, lumen 264 and shaft 252may have any suitable shape and size. For example, shaft 252 may bekeyed to lumen 264. Shaft 252 and/or lumen 264 may have an ovular,polygonal, or other shape. One or both of shaft 252 and/or lumen 264 mayadditionally or alternatively have anchoring mechanisms which mayprevent or limit translational movement between shaft 252 and lumen 264.When tether 240 moves longitudinally with respect to member 220, tool250 may also move longitudinally with respect to member 220. While lumen262 is shown as having a smaller cross-sectional diameter than lumen264, lumen 262 may be larger than lumen 264, or lumens 262 and 264 maybe the same size. While FIGS. 7A-7C depict shaft 222 as having a smallerdiameter than shaft 252, shaft 222 may be the same size as shaft 252 ormay be larger than shaft 222.

FIG. 7B depicts an alternative exemplary configuration of a tetherdenoted 240′. As shown in FIG. 7B, tether 240′ may have an outer surface270 and lumens 272, 274. Surface 270 may include side openings 276, 278in communication with lumens 272, 274. Openings 276, 278 may extend froma proximal portion of tether 240′ to a distal portion of tether 240′.Openings 276, 278 may be parallel to a longitudinal axis of tether 240′.Openings 276, 278 may be disposed approximately 180 degrees apart fromone another. Alternatively, openings 276, 278 may be disposed at asmaller angle from one another. Opening 276 may have a width which issmaller than a diameter of shaft 222 of member 220. Opening 278 may havea width that is smaller than a diameter of shaft 252 of tool 250.

Shaft 222 of member 220 may be slidably disposed in lumen 272. Lumen 272may have any of the properties of lumen 252, described above with regardto FIG. 7A. Tether 240 may have lip portions 280 at either side ofopening 276. Lip portions 280 may be deformable so that shaft 222 may bepressed and/or snapped into lumen 272 via opening 276. Shaft 252 of tool250 may be disposed within lumen 274. Lumen 274 may have any of theproperties of lumen 264, described above with regard to FIG. 7A. Tether240 may have lip portions 282 at either side of opening 278. Lipportions 282 may be deformable so that shaft 252 may be pressed and/orsnapped into lumen 274 via opening 278. As described with regard to FIG.7A, when tether 240 moves longitudinally with respect to member 220,tool 250 may also move longitudinally with respect to member 220. In analternative, a tether may contain one lumen with an opening (forexample, such as lumens 272 and 274) and one lumen without an opening(for example, such as lumens 262 and 264).

FIG. 7C depicts a further exemplary configuration of a tether 240″. Asshown in FIG. 7C, tether 240″ may have a protruding surface 280 that isconfigured to engage with a broken lumen surface 282 of shaft 252 oftool 250. Shaft surface 282 and tether surface 280 may be sized andshaped so as to have an interference fit with one another so as to lockand/or mate to one another, securing the two together as tether 240″translates relative to member 220. Tether surface 280 may be pressedand/or snapped into a lumen defined by shaft surface 282. Shaft 252 mayinclude surface 282 at only a distal portion 254 of tool 250, or shaft252 may include surface 282 along a greater portion of a length of shaft252, such as an entirety or a majority of shaft 252. While shaft surface282 and tether surface 280 are shown in FIG. 7C as being rounded, shaftsurface 282 and tether surface 280 may have any suitable shape and size.For example, shaft surface 282 may be keyed tether surface 280. Shaftsurface 282 and/or tether surface 280 may have an ovular, polygonal,teardrop, or other shape. For example, shaft surface 282 and/or tethersurface 280 may have a hexagonal, a triangular, or a star shape. One orboth of shaft surface 282 and/or tether surface 280 may additionally oralternatively have anchoring mechanisms which may prevent or limittranslational movement between shaft surface 282 and tether surface 280.

Tether 240″ may also have a lumen 284. Lumen 284 may have any of theproperties of lumens 262 and/or 272, described above with regard toFIGS. 7A-7B. A surface of tether 240″ may include an opening 286 that isin communication with lumen 284. In an alternative, tether 240″ may lacksuch opening 286 and lumen 284 may be similar to lumen 262, describedabove. Tether 240 may have lip portions 288 at either side of opening286. Lip portions 288 may be deformable so that shaft 222 may be pressedand/or snapped into lumen 284 via opening 286. As described with regardto FIGS. 7A-7B, when tether 240″ moves longitudinally with respect tomember 220, tool 250 may also move longitudinally with respect to member220.

FIGS. 8A and 8B show exemplary distal portion 224 of member 220. Distalportion 224 may include a surface 302 defining a space that may containcamera portion 226. Surface 302 may be transparent. In an alternative,camera portion 226 may be disposed on any outer surface of shaft 222.Camera portion 226 may be connected to a cable 304 which may providepower and/or control signals to camera portion 226 and/or transmitimages obtained by camera portion 226. Cable 304 may be disposed in alumen 306 of member 220.

Anchor 228 may include an expandable member 310. FIG. 8A showsexpandable member 310 in a collapsed configuration, and FIG. 8B showsexpandable member 310 in an expanded configuration. Expandable member310 may be an inflatable member such as a balloon. The wall of shaft 222of member 220 may include openings 312, 314 therethrough. Openings 312and 314 may be in communication with an interior of expandable member310 and with lumen 306. Air, fluid, or another medium may be passedthrough lumen 306 and through openings 312 and 314 in order to expandexpandable member 310. When expandable member 310 is in an expandedconfiguration (FIG. 8B), expandable member 310 may engage with walls ofa body lumen, such as the body lumen shown in FIG. 6 . Engagement ofexpandable member 310 with walls of a body lumen may serve to anchormember 220 in place so that member 220 may not be longitudinally movablewhen expandable member 310 is in an expanded configuration.

Expandable member 310 may have a variety of shapes and sizes. Alongitudinal length of expandable member (along a longitudinal axis ofmember 220) as well as a radial width of expandable member (extendingorthogonally from member 220) may be any suitable amount. For example,expandable member 310 may have a circular cross section having adiameter of approximately 4-5 mm. In an alternative, expandable member310 may have a hexagonal cross section having a greatest width dimensionof approximately 10 mm. Alternatively, expandable member 310 may haveany other cross-sectional geometry and any diameter or cross-sectionalsize that is effective in anchoring member 220 to a body lumen in anexpanded configuration. For example, a diameter or cross-sectional sizeof expandable member 310 may be approximately 2 mm-5 mm or 2 mm-6 mm.Expandable member 310 may be a non-compliant balloon formed of asemi-rigid material such as PEBAX, PET, or any other suitable material.Alternatively, expandable member 310 may be a compliant balloon formedof a soft durometer material such as silicone, polyurethane, or anyother suitable material.

FIGS. 9A-9B show another exemplary distal portion 224′ of member 220′.FIG. 9A shows a side view of distal portion 224′, and FIG. 9B shows atop view of distal portion 224′ rotated 90 degrees relative to FIG. 9A.Distal portion 224′ may include a surface 320, which along with surface324 of member 220′, defines a lumen that may contain camera portion 226and a cable 326. Surface 320 may project radially outward to form asurface 322 near camera portion 226. Surfaces 320 and/or 322 may betransparent. In addition or in an alternative, camera portion 226 may bedisposed on a surface of shaft 222 (such as surface 324). Camera portion226 may be connected to cable 326, which may provide power and/orcontrol signals to camera portion 226 and/or transmit images from cameraportion 226. Surface 320 may extend proximally from distal portion 224′so that cable 326 passes through a lumen defined by surface 320 insteadof a central lumen (such as lumen 333) of member 220′. In analternative, cable 326 may pass through lumen 333.

Anchor 228′ may include a clipping mechanism 330. Clipping mechanism 330may include a control member 332. Control member 332 may be slidablydisposed in a lumen 333 of shaft 222 so that control member 332 andother portions of clipping mechanism 330 may move longitudinallyrelative to shaft 222. A distal portion of control member 332 may befixed to a proximal portion of a pair of jaws 334. Jaws 334 may includecurved end portions 336. End portions 336 may curve toward one another.Jaws 334 may be moved laterally relative to one another so that they maybe opened and closed. Jaws 334 may be biased toward an openconfiguration. For example, a shape of jaws 334 may be such that jaws334 are biased in an open configuration and/or jaws 334 may be made ofmaterial having shape memory. In a first configuration, control member332 and jaws 334 may be disposed within a lumen of shaft 222. In thefirst configuration, jaws 334 may be in a closed position resulting frompressure exerted by walls of lumen 333 on jaws 334. In a closedposition, tips 336 of jaws 334 may contact one another, may be near toone another, or may overlap one another. Control member 332 may be slidlongitudinally relative to shaft 222 so that jaws 334 extend completelythrough a distal opening 338 of lumen 333 in a second configuration.After clipping mechanism 330 is moved into the second configuration,jaws 334 may be in an open position due to the bias of jaws 334 and theabsence of pressure from the walls of lumen 333. In an openconfiguration, there may be a gap (or a relatively larger gap) betweentips 336.

In order to achieve an anchoring function such as via clamping jaws 334,control member 332 may be retracted into a third configuration so that aproximal end of jaws 334 is within lumen 333. The pressure of the wallsof lumen 333 and/or opening 338 on the proximal ends of jaws 334 maycause tips 336 of jaws 334 to move toward one another. Body tissue thatis between tips 336 of jaws 334 when the clipping mechanism 330 istransitioned to the third configuration may be pinched by tips 336and/or other portions of jaws 334 in the third configuration. Closingjaws 334 around tissue may result in anchoring of clipping mechanism 330and member 220 to the tissue. Jaws 334 may angle away from alongitudinal axis of lumen 333 so that tips 336 extend past an exteriorsurface of shaft 220, toward a side surface of a body lumen, as shown inFIG. 9A. Jaws 334 may each diverge from the longitudinal axis of lumen333 so that jaws 334 are substantially parallel to one another. Anglingof jaws 334 away from the longitudinal axis of lumen 333 may facilitateengagement of jaws 334 with tissue on a size surface of the body lumen.

FIGS. 10A-10B depict another exemplary distal portion 224″ of member220″. The example of FIGS. 10A and 10B may be similar to the example ofFIGS. 9A and 9B, except with respect to the features described below.Anchor 228″ may include an auger member 340. Auger member 340 may havean elongated control member 342 disposed within lumen 333 of shaft 222.Control member 342 may be rotatable relative to shaft 222. A distalportion of control member 342 may be attached to a coil 344. Coil 344may be a corkscrew-type coil that may have one, two, four, or any othersuitable number of coils. A distal end of coil 344 may include a pointedtip 346 that may be sharp. Control member 342 may be longitudinallymovable relative in lumen 333 relative to shaft 222 so that coil 344 maybe retracted into lumen 333 and extended out of opening 338 in lumen333. Coil 344 may be made of a wire and may be made from, for example,stainless steel, elgiloy and other cobalt-containing alloys, nitinol,titanium, platinum or any other suitable material that may be formedinto a coil shape and may have requisite stiffness to maintain the shapeand to move through a tissue of a subject.

Auger member 340 may be transitioned from a first configuration to asecond configuration. In a first configuration (FIG. 10A), coil 344 maybe navigated to a target site within a lumen of a subject. Coil 344 thenmay rest against a wall 360 of a body lumen without engaging the tissueof the wall 360. Auger 340 may be transitioned to a second configuration(FIG. 10B) by rotating control member 342 about its own axis. Rotationof control member 342 may cause rotation of coil 344. Pointed tip 346 ofcoil 344 may pierce a tissue surface of a wall 360 of the body lumen.Continued rotation of control member 342 may cause pointed tip 346 topass through tissue before exiting into the body lumen again. Coil 344may continue to pierce and/or pass through the tissue with continuedrotation of control member 342. Engagement of coil 344 with the tissuemay cause member 220″ to be fixed in a desired location in the bodylumen.

FIGS. 11A-11C depict exemplary steering mechanisms. As shown in FIG.11A, member 220 (like member 220 in FIG. 6 ) may be navigated to adesired location by a steering member 400. Steering member 400 may becoupled to tether 240 (like tether 240 in FIG. 6 ). For example, shaft402 of steering member 400 may be inserted into a lumen of tether 240.An end cap portion 404 of steering member 400 may restrain steeringmember 400 so that it remains coupled with tether 240. Steering member400 may have an interference fit with a lumen of tether 240. Steeringmember 400 may have any of the properties of tool 252, described above,including those described with regard to FIGS. 7A-7C. Tether 240 mayalso have any of the properties described above, including thosedescribed with regard to FIGS. 7A-7C. Steering member 400 may also havea steering mechanism 410 that may be disposed inside of steering member400 (e.g., in a lumen of shaft 402) or outside of shaft 402. FIG. 11Adepicts an exemplary embodiment wherein steering mechanism 410 isdisposed within a lumen of shaft 402 for a portion of a length of shaft402 and is disposed outside of shaft 402 at another portion of a lengthof shaft 402. Steering mechanism 410 may exit shaft 402 via a hole nearthe distal end of shaft 402. Steering mechanism 410 may be, for example,a wire or a cable or any other suitable mechanism. Member 220 may alsobe slidably secured to tether 240, using any of the methods ormechanisms described above.

After steering member 400 and member 220 are coupled to tether 240,steering member 400, member 220, and tether 240 may be advanced througha lumen 214 of an insertion portion 210. Interaction between tether 240and distal portion 224 of member 220 (e.g., the distal end of tether 240abutting the proximal end of an enlarged portion of distal portion 224)may cause member 220 to be advanced along with tether 240 and steeringmember 400. Steering member 400, member 220, and tether 240 may extendout of a distal opening of lumen 214 and advanced distally of insertionportion 210. A relatively smaller size of tether 240, steering member400, and member 220 may allow those components to reach narrower bodylumens, such as bronchial lumens, than could be reached by insertionportion 210.

Steering mechanism 410 may extend proximally through a lumen 214 ofinsertion portion 210 to a control device. Actuation of steeringmechanism 410 may cause bending of a distal portion of steering member400, as shown in FIG. 11B. For example, actuation of steering mechanism410 may cause a shortening of steering mechanism 410. After steeringmember 400 is used to position member 220 in a desired location of asubject's body lumen, member 220 may be anchored using anchor member228. Steering member 400 and tether 240 may then be retracted throughlumen 214 so that an operator may detach steering member 400 from tether240. A tool 250 may then be secured to tether 240 and advanced throughlumen 214 of insertion portion 210. Member 220 may act as a guidewirefor tether 240 and tool 250. Tether 240 may ride along shaft 222 ofmember 220 so that tool 250 can be transported to a location ofinterest, proximate to distal portion 224 of member 220. Tool 250 maythen be used to conduct a variety of diagnostic or treatment procedureson a subject. Tool 250 may eventually be retracted through lumen 214 andreplaced by another tool 250, using the method described above. Theabove process may be repeated any number of times. At the end of aprocedure, anchor portion 228 may be disengaged so that member 220 is nolonger secured to a body lumen of a subject. Member 220 may then beretracted through lumen 214.

FIG. 11C shows an exemplary alternative configuration wherein member 220includes a steering mechanism 450 such as a steering wire or cable orany other suitable mechanism. Steering mechanism 450 may have any of theproperties of steering mechanism 410, described above. Steeringmechanism 450 may be disposed inside of member 220 (e.g., in a lumen ofshaft 222) or outside of shaft 222. FIG. 11C depicts an exemplaryembodiment wherein steering mechanism 450 is disposed within a lumen ofshaft 222 for a portion of a length of shaft 222 and is disposed outsideof shaft 222 at another portion of a length of shaft 402. Actuation ofsteering mechanism 450 may cause bending of a distal portion of member220, as shown in FIG. 11C. For example, actuation of steering mechanism450 cause a shortening of steering mechanism 450.

In use, member 220 may be advanced toward a desired location of asubject's body lumen. Steering mechanism 450 may aid in suchpositioning. Member 220 may then be anchored using anchor member 228. Atool 250 may then be secured to tether 240. Tether 240 may be secured tomember 220 if it is not already secured to member 220. Tool 250 andtether 240 may then be advanced through lumen 214 of insertion portion210. Member 220 may act as a guidewire for tether 240 and tool 250.Tether 240 may ride along shaft 222 of member 220 so that tool 250 canbe transported to a location of interest, proximate to distal portion224 of member 220. Tool 250 may then be used to conduct a variety ofdiagnostic or treatment procedures on a subject. Tool 250 may eventuallybe retracted through lumen 214 and replaced by another tool 250, usingthe method described above. The above process may be repeated any numberof times. At the end of a procedure, anchor portion 228 may bedisengaged so that member 220 is no longer secured to a body lumen of asubject. Member 220 may then be retracted through lumen 214.

While principles of the present disclosure are described herein withreference to illustrative examples for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications, andsubstitution of equivalents all fall within the scope of the examplesdescribed herein. Accordingly, the invention is not to be considered aslimited by the foregoing description.

We claim:
 1. A medical device comprising: a handle portion; an insertionportion having a proximal end portion at the handle portion, wherein theinsertion portion includes a lumen therein and a distal end having adistal opening in communication with the lumen; and a member disposedwithin the lumen, the member having a distal end portion with an imagingdevice; wherein the member is configured to transition between a firstconfiguration and a second configuration, wherein, in the firstconfiguration, the distal end portion of the member is angled to form anL-shape relative to a more proximal portion of the member adjacent toand proximal of the distal end portion, such that the imaging devicefaces distally, and, in the second configuration, the imaging devicefaces proximally, and wherein extending the distal end portion of themember distally past the distal opening causes the member to transitionfrom the first configuration to the second configuration.
 2. The medicaldevice of claim 1, wherein the member includes a flat shaft having across sectional width greater than a thickness and having at least onesubstantially planar outer surface.
 3. The medical device of claim 2,wherein the shaft and a distal end of the shaft is ribbon shaped.
 4. Themedical device of claim 2, wherein the imaging device is disposed on aside surface proximal to a distal end of the member.
 5. The medicaldevice of claim 1, wherein, in the second configuration, the distal endportion of the member forms a curl shape.
 6. The medical device of claim1, wherein the member is configured to transition between the firstconfiguration and the second configuration by moving the memberlongitudinally relative to the lumen.
 7. The medical device of claim 6,wherein a proximal portion of the member is coupled to a hub, andwherein the hub is configured to effect longitudinal movement of themember relative to the lumen as the hub translates relative to thehandle portion.
 8. The medical device of claim 1, wherein the memberincludes a shaft and a second lumen extending from a proximal end of theshaft to a distal end of the shaft, wherein the second lumen terminatesin a second distal opening at the distal end of the shaft.
 9. Themedical device of claim 8, wherein the second distal opening terminatesat an angle transverse to a longitudinal axis of the shaft.
 10. Themedical device of claim 1, wherein a cross-section of the member iscircular.
 11. The medical device of claim 1, wherein the member iscomprised of a shape memory material.
 12. The medical device of claim 1,further comprising a tool disposed within the lumen.
 13. A medicaldevice comprising: a shaft having a lumen extending from a proximal endof the shaft to a distal end of the shaft, wherein the lumen terminatesin a distal opening at the distal end of the shaft; and a memberdisposed within the lumen, the member having a ribbon shape with aterminal end and an imaging device spaced from the terminal end, whereinthe member is configured to transition between a first configuration anda second configuration, wherein, in the first configuration, a distalend portion of the member is proximal to the distal opening of the shaftand the distal end portion of the member forms an L-shape relative to amore proximal portion of the member adjacent to and proximal of thedistal end portion, such that the imaging device faces distally, and, inthe second configuration, the imaging device faces proximally, andwherein extending the distal end portion of the member distally past thedistal opening causes the member to transition from the firstconfiguration to the second configuration.
 14. The medical device ofclaim 13, wherein the member comprises a second lumen extending from theproximal end to the distal end, wherein the second lumen terminates in asecond distal opening at the distal end of the shaft.
 15. The medicaldevice of claim 14, wherein the second distal opening terminates at anangle transverse to a longitudinal axis of the shaft.
 16. The medicaldevice of claim 13, wherein the ribbon shape has a cross sectional widthgreater than a thickness and at least one substantially planar outersurface.
 17. The medical device of claim 13, further comprising a tooldisposed within the lumen.
 18. The medical device of claim 13, wherein,in the second configuration, the distal end portion of the member formsa curl shape.
 19. The medical device of claim 13, further comprising ahandle portion coupled to a proximal portion of the shaft, wherein aproximal portion of the member is coupled to a hub, and wherein the hubis configured to effect longitudinal movement of the member relative tothe lumen as the hub translates relative to a handle portion.
 20. Themedical device of claim 13, wherein the member is comprised of a shapememory material.